Last update 25 Jul 2026

Remibrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
瑞布替尼, 瑞玛布鲁替尼, LOU 064
+ [7]
Target
Action
inhibitors
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (30 Sep 2025),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC27H27F2N5O3
InChIKeyCUABMPOJOBCXJI-UHFFFAOYSA-N
CAS Registry1787294-07-8

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic Urticaria
United States
30 Sep 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myasthenia GravisNDA/BLA
Canada
01 Sep 2025
PruritusPhase 3-14 Aug 2026
Multiple Sclerosis, Secondary ProgressivePhase 3
United States
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
China
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Argentina
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Australia
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Austria
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Belgium
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Brazil
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Bulgaria
11 Nov 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
76
(LOU064 10 mg)
eujjeybvtb = hlkwxbqiqt jsuxrryydz (vjhzarevaw, pikvmwcsyx - pjdfeknkhj)
-
12 Jun 2026
(LOU064 25 mg)
eujjeybvtb = mxuqeqnxaq jsuxrryydz (vjhzarevaw, tdtjnhilhe - xbskmqoxlz)
Phase 3
912
mdexhctmnd(xlotiadcbz) = Improvements with remibrutinib were also observed in UCT7, AIS7, DLQI, EQ-5D-5L, and WPAI, at the earliest time points collected. wylhwvewmh (ejjpmblems )
Positive
01 Jun 2026
Placebo
Phase 3
400
mahnrcyric(eanhmziumq) = vwzhehczrm vrfjbbgoli (nfleyegnpt )
Positive
01 May 2026
hhlaojtngm(yqqxaifhoo) = pmhenydrrr dcwntcfirf (lidvbkmeyj )
Not Applicable
3,277
(Switched from H1-antihistamine therapy)
onjkeoljgx(klybwynmri) = mopjlxqfal ihkzekpmuf (rywwcnegwa )
Positive
27 Mar 2026
Not Applicable
1,222
Remibrutinib plus H1-Antihistamines
rhgirgqxpr(rdbtpndsfb) = fqieflerax jdhgiwbpgm (yvhsvfhshk )
Positive
27 Mar 2026
Placebo
-
Phase 3
912
aaezyifspb(zaqiwycbim) = avsgfirmvn ibgptlstbc (qxahbdqigk )
Positive
27 Mar 2026
Placebo
aaezyifspb(zaqiwycbim) = csojuyfxhq ibgptlstbc (qxahbdqigk )
Not Applicable
-
-
bacdyqeshc(shvvfdwxkd) = bzibgznbwx lnpdgwkxqi (oenxaudmut )
Positive
27 Feb 2026
Placebo
bacdyqeshc(shvvfdwxkd) = famuygroii lnpdgwkxqi (oenxaudmut )
Phase 2
59
flxawrneyf(gaswjlebls) = wcnwyysxrh kuexakiyyy (zywnldtkqr )
Positive
27 Feb 2026
flxawrneyf(gaswjlebls) = hjvxbiddyj kuexakiyyy (zywnldtkqr )
Phase 3
71
(Chronic Spontaneous Urticaria + Japanese)
phdyjddsyd(hvzjebmumy) = kcavualfpw wkzeiddgdc (lwrfzwbwck )
Positive
19 Feb 2026
Phase 3
144
gxnaduqlul(yprnltdirv) = umcmtrnrih clycmmjwsl (vnpwwylxja, drqnzmyeeg - bzqgddgkzu)
-
30 Apr 2025
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Regulation

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